Abstract
Objectives
COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination related adverse events (ADEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey.
Methods
The survey was circulated in early 2021 by > 110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details, and 7-day vaccine ADEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type.
Results
10900 respondents [42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 5,867 patients (54%) with SAIDs were compared with 5033 HCs.
79% had minor and only 3% had major vaccine ADEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs=26%, HCs=24%; OR = 1.1 (1.03-1.3); p = 0.014], abdominal pain [SAIDs=2.6%, HCs=1.4%; OR = 1.5 (1.1-2.3); p = 0.011], and dizziness [SAIDs=6%, HCs=4%; OR = 1.3 (1.07-1.6); p = 0.011], were slightly more frequent in SAIDs. Overall, major ADEs [SAIDs=4%, HCs=2%; OR = 1.9 (1.6-2.2); p < 0.001] and, specifically, throat closure [SAIDs=0.5%, HCs=0.3%; OR = 5.7 (2.9-11); p = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major ADEs and hospitalizations (less than 2%) were comparable across vaccine types in SAIDs.
Conclusion
Vaccination against COVID-19 is relatively safe in SAID patients. SAIDs were at a higher risk of major ADEs than HCs, though absolute risk was small. There are small differences in minor ADEs between vaccine types in SAID patients.
Keywords: adverse reaction, autoimmune disease, COVID-19, rheumatic disease, vaccine
Contributor Information
Parikshit Sen, Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi-110002, India.
Naveen R, Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Arvind Nune, Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK.
James B Lilleker, Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre,The University of Manchester, Manchester, UK; Neurology Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK.
Vishwesh Agarwal, Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
Sinan Kardes, Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Capa-Fatih, 34093, Istanbul, Turkey.
Minchul Kim, Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Illinois, USA.
Jessica Day, Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia; Walter and Eliza Hall Institute of Medical Research, Parkville, VIC 3052 Australia; Department of Medical Biology, University of Melbourne, Parkville, VIC 3052 Australia.
Marcin Milchert, Department of Internal Medicine, Rheumatology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, ul Unii Lubelskiej 1, 71-252, Szczecin, Poland.
Tamer Gheita, Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
Babur Salim, Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
Tsvetelina Velikova, Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz", Sofia University St. Kliment Ohridski, 1 Kozyak Str., 1407, Sofia, Bulgaria.
Abraham Edgar Gracia-Ramos, Department of Internal Medicine, General Hospital, National Medical Center “La Raza”, Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990 Mexico City, Mexico.
Ioannis Parodis, Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Albert Selva O’Callaghan, Internal Medicine Department, Vall D'hebron General Hospital, Universitat Autonoma de Barcelona, 08035 Barcelona, Spain.
Elena Nikiphorou, Centre for Rheumatic Diseases, King’s College London, London, UK; Rheumatology Department, King's College Hospital, London, UK.
Tulika Chatterjee, Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Illinois, USA.
Ai Lyn Tan, NIHR Leeds Biomedical Research Centre,Leeds Teaching Hospitals Trust, Leeds, UK; Leeds Institute of Rheumatic and Musculoskeletal Medicine,University of Leeds, Leeds, UK.
Lorenzo Cavagna, Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia, Pavia, Lombardy, Italy.
Miguel A Saavedra, Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
Samuel Katsuyuki Shinjo, Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Nelly Ziade, Rheumatology Department, Saint-Joseph University, Beirut, Lebanon; Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
Johannes Knitza, Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Deutschland.
Masataka Kuwana, Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan.
Oliver Distler, Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Hector Chinoy, Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre,The University of Manchester, Manchester, UK; National Institute for Health Research Manchester Biomedical Research Centre,Manchester University NHS Foundation Trust,The University of Manchester, Manchester, UK; Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
Vikas Agarwal, Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Rohit Aggarwal, Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Latika Gupta, Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India; Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, WV10 0QP, United Kingdom; Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre,The University of Manchester, Manchester, UK.
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